GUEST COLUMNISTS

  • AI & Intelligent Technologies: Finding The Right Fit For Your Pharma Or Medtech Company

    This article takes a closer look at AI and intelligent technologies in biotech, medical devices, and pharma, and what we can expect to tackle in 2022 and beyond. The article also identifies some of the new concerns and challenges with disruptive technologies and risk management, and discusses a technology and generation timeline.

  • 4 Tips For Medical Device Design Success

    We are all eagerly anticipating what 2022 will bring us. This author found that when developing a forward vision, it always helps to look back and see what we learned in the past. He uses some personal experiences of designing surgical robotics for these 4 tips.

  • Merck’s 2 Lessons Learned In Overcoming Single-Use Materials Supply Challenges

    The COVID-19 pandemic has caused severe disruption to supply chains, making it difficult to get material. At Merck, a situation occurred recently wherein they were unable to get the filter assembly they needed, and their supplier was struggling to meet demand. This article shares Merck's two lessons learned from the experience.

  • 2021’s Bioprocessing Year In Review & 7 Key Takeaways

    The biopharma and bioprocessing industries have responded aggressively and effectively to the COVID-19 pandemic. However, supply chain challenges, shortages, hiring problems, and regionalization have accelerated existing trends and created the need for new strategies. These are just a few of the findings presented in BioPlan Associates’ 2021 18th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production.

  • Calculating Cleaning Process Capability: Analysis Of Total Organic Carbon

    This article will examine a data set of actual total organic carbon (TOC) swab data collected during cleaning validation for a pharmaceutical manufacturing facility and will show how much cleaning process knowledge and cleaning process understanding can be easily obtained through some simple statistical evaluations of such data.

  • Regulatory Perspectives For CGT Development: Continued Need For Standards And Perseverance

    The need for standards not only lies in the identification and development of standards, but also in implementation.

  • Are You Leveraging KOLs For Biopharma Market Access As Much As You Could Be?

    Pharmaceutical companies spend a lot of time and effort engaging and collaborating with key opinion leaders (KOLs), an exercise typically owned by medical affairs. But few take advantage of network mapping tools and relationship-building principles from a market access lens to help inform and shape coverage strategies and identify access champions for their products.

  • How Can We Use The UDI To Improve The Device Recall Process?

    The Unique Device Identifier (UDI) was expected to improve patient and medical device safety by enhancing key patient safety systems like the product recall and adverse event reporting processes and improving device evaluation. AHRMM recently completed a survey of various stakeholders; this article delves into the survey's findings and the recommendations for improving the device recall process.

PHARMA OUTSOURCING WHITE PAPERS

  • Strategies For Flexible Manufacturing

    Custom-designed equipment and suites, flexible manufacturing lines, and alternative delivery and manufacturing approaches are critical to achieving a timely and successful launch in a competitive marketplace.

  • Quantification Of Vector Genomic, Residual DNA In Gene Therapy Vectors

    Bringing cell and gene therapy drugs to market requires improvement in many areas, including analytical testing methods, which are used to determine the safety, strength, and purity of viral vectors.

  • The Shift Toward US Pharmaceutical Manufacturing

    The pandemic has brought the global interdependency of pharmaceutical supply chains into sharp focus, exposing weak links and re-igniting discussions around the value of reshoring production. Explore effective strategies to secure and de-risk pharmaceutical supply chains.

  • Using Single-Use Connectors To Increase The Integrity Of Closed Systems

    Minimizing the threat of contamination using a closed system during drug development and manufacturing is critical. While single-use connectors can reduce many of the risks associated with tube welding, it is essential the ones you select meet the sterility and reliability needs of your application.

  • User Experience For Manual Injection Of 2 mL Viscous Solutions Is Enhanced By A New Prefillable Syringe

    Although subcutaneous administration improves patient compliance and quality of life by enabling at-home injections, as compared to intravenous or intramuscular route, the associated anxiety, pain, discomfort, and the frequency of injections can play a significant role in patient non-adherence with chronic subcutaneous treatments. In order to address these challenges, through reducing the required frequency of subcutaneous injections and increasing injection comfort for novel biotherapeutics, drug delivery systems are needed to enable the administration of large-volume injections and/or high-viscosity drugs. We developed a pre-fillable glass syringe featuring a stacked 8 mm needle with an ultra-thin wall (UTW) cannula technology as a solution.

  • Analyzing Product Formulation Using Raman Microscopy

    Raman spectroscopy is used to compare the dissolution rates and pellet fine structure of branded Sporanox® with three similar generic products marketed across the world, all containing the same API.

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OUTSOURCED PHARMA CONTENT COLLECTIONS

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We’ve collected four of Outsourced Pharma Chief Editor Louis Garguilo’s editorials with outsourcing professionals to help you understand what they and the entire industry is experiencing, what you can expect in 2022, and some steps you might be able to take to mitigate these market forces.

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